My Choices: Efficacy and Implementation Study

NCT05358613 | Completed

• 1 other identifier: CER-18-251-10.02
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of the study is to assess the efficacy of the My Choices - Alcohol program by comparing alcohol-use of people before and after doing the program to people that did not do the program on the same period of time (3 months).

Conditions

Alcohol Use Disorder, Mild; Alcohol Use, Unspecified

Keywords

Alcohol; Treatment

Outcome Measures

Primary Outcomes (4)

• Change in self-reports of alcohol with the time-line follow-back (TLFB) in the last 90 days

  The timeline follow-Back is a research tool to obtain self-reported quantitatives estimates of alcohol used every day in the last 3 months in term of standard drink. (Sobell \& Sobell) Participants are asked in the first interview (2 weeks within eligibility evaluation) to remember day by day how many standard drinks they have had in the last 90 days.

  2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

• Change in the Short Alcohol Dependance Data Questionnaire (SADD)

  Short Alcohol Dependence Data questionnaire (SADD) is used to measure the severity of alcohol dependence. It comprises 15 items with a four-point frequency scale (never,sometimes, often, nearly always). A total score between 0 and 45 is obtained by adding the score from each of the items. Scores between 0 - 9 indicates low dependence, scores between 10 - 19 indicates medium dependence and a score of 20 or more indicates high dependence.

  2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

• Change in the Inventory of consequences associated with alcohol use

  It is a 7-items questionnaire, with a 0-10 (Never to always) scale that measures the consequences of alcohol consumption.

  2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

• Change in the Severity of dependence scale (SDS)

  The Severity of Dependence Scale (SDS) is a 5-item self-administered questionnaire that provides a score indicating the severity of dependence on drugs with a 4-point scale from 0 (Never) to 3 (Always). Score 0 indicates no dependence, score between 1-2 indicates low dependence, score between 3-5 indicates moderate dependance and score between 6 and 15 indicates a high dependance.

  2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

Secondary Outcomes (19)

• Satisfaction with Life Domains Scale

  2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

• Medical Outcomes Study-Social Support Survey (MOS-SSS)

  2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

• Readiness to change

  2 weeks within eligibility evaluation

• Motivations to change

  2 weeks within eligibility evaluation

• Generalized Anxiety Disorder (GAD-7)

  2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

Study Arms (2)

Immediate treatment

EXPERIMENTAL

The My Choices program will be offered immediately (maximum 10 working days from their first research interview) to the participants of this group. The treatment will be dispensed as usual, wich means there are no special conditions that need to be respected specifically for the study.

Behavioral: My Choices

Waiting list

ACTIVE COMPARATOR

The My Choices program will be offered 3 months after the first research interview to the participants in this group. The treatment will be dispensed as usual, wich means there are no special conditions that need to be respected specifically for the study.

Behavioral: My Choices

Interventions

My Choices BEHAVIORAL

The My Choices program is an harm reduction program to modify substance use habits. It is based on the Miller \& Rollnick Motivational interviewing as well as Deci and Ryan's Self-determination theory and Bandura's social learning theory. It is presented as a guide, divided in 6 phases. In every phase, participants will find, in the guide, some auto-observation exercises about their alcohol use habits and other aspects about their quality of life, reflexions and information about alcohol. The participants are also invited to note the number of standard units of alcohol they use on every occasion.

Also known as: Alcochoix+

Immediate treatment; Waiting list

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with at risk alcohol use (alcohol use over the Canadian low-risk alcohol drinking guidelines, without or with low consequences associated with their alcohol use).

You may not qualify if:

• Score at the DEBA (Assessment and Screening of Assistance needs) indicates a need for specialized treatment.
• Hospitalization for mental health problems in the last 30 days
• People with unstable mental health condition

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead

Study Sites (5)

Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean

Jonquière, Quebec, G7X 3A9, Canada

Location

Centre Intégré de Santé Services Sociaux de Laval

Laval, Quebec, H7M 3L9, Canada

Location

Centre intégré de Santé et de Services Sociaux de Chaudière-Appalaches

Lévis, Quebec, G6V 0M4, Canada

Location

Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale

Québec, G1J 0A4, Canada

Location

Université du Québec à Trois-Rivières

Québec, G1M 3E5, Canada

Location

MeSH Terms

Conditions

Alcoholism; Lymphoma, Follicular; Alcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Drinking Behavior; Behavior

Study Officials

• Joël Tremblay, Ph.D.

  Université du Québec à Trois-Rivières

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized to either receive the treatment now (10 working days, experimental group) or in 3 months (control group).

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 3, 2022
• Study Start: October 28, 2021
• Primary Completion: May 14, 2023
• Study Completion: May 14, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)